Design Controls

The FDA requires proof of compliance with established design control procedures during the product design and development phase. Medical device manufacturers need to maintain records known as Design History Files (DHF) documenting compliance with established design control procedures, and have them ready for regulatory inspection once they obtain market authorization for their medical device. MCRA’s experts can show you how to properly create and maintain DHF to ensure a more efficient quality assurance down the line. MCRA’s design control services include the following:


  • Design History File (DHF) reviews and remediation
  • Implementation of design control process
  • Facilitation of design review meetings

To contact a quality assurance expert at MCRA, call 202.552.5800 or email

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise



Quality Assurance

Mr. Biggins has over twenty years of experience in the area of Quality Systems and Manufacturing beginning as a Quality Engineering Manager. Mr. Biggins is an expert at Quality Management Systems, specifically in the areas of Corrective and Preventive Action (CAPA), Customer Complaints, Design Control Read More

PH: 202.552.5800